Oral Temperature Digital Thermometer 16811

GUDID 20612606001516

Dual Scale Oral Digital Thermometer, 60 second read

KERMA MEDICAL PRODUCTS, INC.

Intermittent electronic patient thermometer

• Primary Device ID: 20612606001516
• NIH Device Record Key: 960ae9c9-a430-45b8-b4b8-20083d97dfe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oral Temperature Digital Thermometer
• Version Model Number: 16811
• Catalog Number: 16811
• Company DUNS: 787328772
• Company Name: KERMA MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612606001512 [Primary]
GS1	20612606001516 [Package]; Contains: 00612606001512; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940686

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-18

On-Brand Devices [Oral Temperature Digital Thermometer]

• 20612606001523: Dual Scale Oral Digital Thermometer with 20 Probe Covers, 60 second read
• 20612606001516: Dual Scale Oral Digital Thermometer, 60 second read